Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Cognitive Rehabilitation for Gulf War Illness

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02161133
Recruitment Status : Completed
First Posted : June 11, 2014
Results First Posted : June 4, 2020
Last Update Posted : August 26, 2020
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

Brief Summary:
There are almost 700,000 Gulf War Veterans (GWV) with 25-30% suffering from a devastating multi-symptom illness coined Gulf War Illness (GWI). GWV with GWI report significant activity limitations and chronic cognitive problems consistent with problem-solving deficits. Problem-solving is considered the most complex of cognitive abilities and is what enables us to conduct complicated behaviors such as setting goals, sequencing and multi-tasking. As a result studies have found that problem-solving deficits are prospectively related to a greater risk of disability. Despite published reports documenting these problems there are no treatments that target the problem-solving deficits of GWI. This proposal seeks to determine whether Problem-Solving Therapy, a patient centered cognitive rehabilitation therapy, can reduce disability by compensating for problem-solving deficits.

Condition or disease Intervention/treatment Phase
Gulf War Illness Behavioral: Problem-Solving Therapy Behavioral: Health Education Not Applicable

Detailed Description:

Gulf War Illness (GWI) is a complex multi-dimensional illness which causes as much disability as other major medical diseases. Previous clinical trials (i.e. cognitive behavioral therapy and graded exercise) for GWI have sought to improve disability by increasing activity regardless of symptom presentation. These previous trials for GWI have shown limited efficacy and poor adherence. An innovative treatment approach is to target a specific component of GWI, namely problem-solving ability, known to be associated with disability.

Impairment in problem-solving ability affects Gulf War Veterans (GWV) with GWI and is prospectively related to greater risk of disability. This impairment is also related to poorer adherence to medical regimes, making it difficult for GWV to manage other aspects of GWI. Problem-solving is considered one of the most complex of cognitive abilities and is related to complicated behaviors such as setting goals, sequencing and multi-tasking. Despite published reports documenting these deficits there are no treatments that target the problem-solving deficits of GWI in order to reduce disability.

The investigators propose a targeted treatment, Problem-Solving Therapy, to compensate for the problem-solving deficits of GWI and thereby reducing disability. Problem-Solving Therapy, a top down approach, teaches patients skills to overcome problems like cognitive dysfunction or physical symptoms that impact problem-solving. Compensating for problem-solving deficits would reduce disability and provide information on the effect of treating one component of GWI on other symptoms of GWI. This is the first trial of cognitive rehabilitation therapy for GWI.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 268 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Cognitive Rehabilitation for Gulf War Illness
Actual Study Start Date : January 1, 2015
Actual Primary Completion Date : December 31, 2018
Actual Study Completion Date : September 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation

Arm Intervention/treatment
Experimental: Problem-Solving Therapy
Problem-Solving Therapy is a treatment approach that teaches patients strategies to address real-life problems.
Behavioral: Problem-Solving Therapy
Problem-Solving Therapy is a treatment approach that teaches patients strategies to address real-life problems.

Active Comparator: Health Education
Health education provides didactic information about Gulf War Illness
Behavioral: Health Education
Health Education provides didactic information about Gulf War Illness




Primary Outcome Measures :
  1. Disability - WHO-DAS 2 Change [ Time Frame: Baseline and 12 weeks ]

    World Health Organization Disability Assessment Schedule.

    The WHO-DAS 2.0 measures disability due to physical and mental health conditions. The WHO-DAS 2.0 is a 36 item measure that focuses upon six life tasks:

    • Understanding and communicating
    • Self-care
    • Mobility (getting around)
    • Interpersonal relationships (getting along with others)
    • Work and household roles (life activities)
    • Community and civic roles (participation)

    These six life tasks reflect two underlying constructs: Activity limitations and Participation deficits. Scores range from 0-100 with higher scores = more disability.



Secondary Outcome Measures :
  1. Problem-Solving Inventory Change [ Time Frame: Baseline and 12 weeks ]
    Self-report problem-solving ability. Scores range from 32-192 with lower scores equally better problem-solving ability.

  2. Problem-Solving Ability Change [ Time Frame: Baseline and 12 weeks ]
    Neuropsychological Battery includes: Halstead Category Test, Russell Revised Version, The Conner's Continuous Performance Test-3 (CPT-3), Stroop Color and Word Test, Trails Making Test A and B (TMT). Problem-solving ability was be created by standardizing (i.e., converting to z-scores) these neuropsychological tests based on administrative norms and averaging them. The Z-score indicates the number of standard deviations away from the mean. A Z-score of 0 is equal to the mean of a reference population (i.e., healthy, age and sex-matched). Negative numbers indicate values lower than the reference population and positive numbers indicate values higher than the reference population and higher scores reflecting greater problem solving.

  3. Disability - WHO-DAS 2 Change [ Time Frame: Baseline and 6 months ]

    World Health Organization Disability Assessment Schedule.

    The WHO-DAS 2.0 measures disability due to physical and mental health conditions. The WHO-DAS 2.0 is a 36 item measure that focuses upon six life tasks:

    • Understanding and communicating
    • Self-care
    • Mobility (getting around)
    • Interpersonal relationships (getting along with others)
    • Work and household roles (life activities)
    • Community and civic roles (participation)

    These six life tasks reflect two underlying constructs: Activity limitations and Participation deficits. Scores range from 0-100 with higher scores = more disability.


  4. Problem-Solving Inventory Change [ Time Frame: Baseline and 6 months ]
    Self-report problem-solving ability. Scores range from 32-192 with lower scores equally better problem-solving ability.


Other Outcome Measures:
  1. Pain Disability Change [ Time Frame: Baseline and 12 weeks ]
    Pain Disability Index (PDI). Scale ranges from 0-70 with higher scores meaning worse disability.

  2. Multidimensional Pain Inventory - Pain Severity Subscale Change [ Time Frame: baseline and 12 weeks ]
    three items assessing pain severity. scores range 0-18 with higher scores=worse severity

  3. Fatigue Change [ Time Frame: Baseline and 12 weeks ]
    The Fatigue Severity Scale (FSS). Scale from 9 to 63 with higher scores = worse fatigue



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Inclusion:

  • deployed to first Gulf War and meets Kansas definition for GWI (see definition in measures section);
  • scores at least a half a standard deviation worse than the mean on the World Health Organization Disability Schedule (WHO-DAS II).

Exclusion Criteria:

Exclusion:

  • current suicidal/homicide intent or plan assessed by The Columbia Suicide Severity Rating Scale, schizophrenia or current psychotic symptoms
  • self-reported diagnosis of a degenerative brain disorder or serious psychiatric or medical illness which may limit generalizability of the findings, limit safety or account for the symptoms of GWI.

Exclusionary medical illnesses include: Class 3 and 4 heart failure, cancer diagnosed within the past year and/or undergoing active treatment (chemotherapy or radiation therapy), chronic renal insufficiency, hospitalization due to myocardial infarct, stroke in the past year, a neurodegenerative disorder, or another medical or psychiatric disorder that may limit generalizability, limit participants safety or account for the symptoms of GWI at the discretion of the PI.

  • a disability that would preclude telephone use.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02161133


Locations
Layout table for location information
United States, Massachusetts
Edith Nourse Rogers Memorial Veterans Hospital, Bedford, MA
Bedford, Massachusetts, United States, 01730
United States, New Jersey
East Orange Campus of the VA New Jersey Health Care System, East Orange, NJ
East Orange, New Jersey, United States, 07018
United States, New York
Canandaigua VA Medical Center, Canandaigua, NY
Canandaigua, New York, United States, 14424
Sponsors and Collaborators
VA Office of Research and Development
Investigators
Layout table for investigator information
Principal Investigator: Lisa M McAndrew, PhD East Orange Campus of the VA New Jersey Health Care System, East Orange, NJ
  Study Documents (Full-Text)

Documents provided by VA Office of Research and Development:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT02161133    
Other Study ID Numbers: SPLD-009-13S
First Posted: June 11, 2014    Key Record Dates
Results First Posted: June 4, 2020
Last Update Posted: August 26, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by VA Office of Research and Development:
Veterans
neuropsychology
fatigue
Chronic Multisymptom Illness
Gulf War Illness
behavioral treatment